COVID-19 Vaccines: Information Updates
Prescribing Information (all COVID-19 vaccines currently being used in Ireland)
Latest Updates (latest EMA updates and usage statistics)
Latest Safety Assessments (latest EMA safety assessments)
All Updates (all EMA updates to date)
Prescribing information for all COVID-19 vaccines currently being used in Ireland
Class information is based on the vaccines currently being used in Ireland. In order to improve traceability of biological medicinals, clearly record the name and the batch number of the administered product.
Contraindications (CI): Hypersensitivity to any member of the class, vaccine component, trace substances after manufacture or following previous admin of a similar vaccine. Use of live viruses with immunosuppression (chemo- or radiotherapy, organ or bone marrow transplantation and/or currently on immunosuppressives including corticosteroids); impaired cell-mediated immunity (HIV infection, Severe Combined Immunodeficiency Syndrome, Di George Syndrome or congenital/hereditary immunodeficiency; severe humoral or cellular, primary or acquired immunodeficiency).
Special Precautions (SP): Hypersensitivity and anaphylaxis. Appropriate medical treatment and supervision to be available in case of anaphylactic reaction. Close observation for minimum 15 minutes after vaccination.
Anxiety-related reactions e.g. vasovagal reactions (syncope), hyperventilation or stress-related reactions (dizziness, palpitations, increased heart rate, altered blood pressure, paraesthesia, hypoaesthesia, sweating) may occur in association with the vaccination process itself. Usually temporary and resolve on their own. Advise vaccinees to bring symptoms to attention of vaccination provided to evaluate. Ensure precautions to avoid injury from fainting.
Concurrent illness, postpone (acute severe febrile illness, acute infection); do not delay (minor infection, low-grade fever).
Thrombocytopenia, any coagulation disorder, individuals receiving anticoagulants, weigh risk/benefit of using IM route (bleeding or bruising may occur following IM admin). Vaccines may not protect 100% of recipients; reduced immunogenicity in immuno-compromised (immunosuppressive therapy, genetic causes). Duration of protection is still being determined by ongoing clinical trials.
Driving: Possible side-effects may affect ability. Do not drive if feeling unwell after vaccination.
ATC Code: J07BX03.
Indication(s): Active immunisation to prevent, COVID-19 disease caused by SARS-CoV-2 virus from age 12 years (Comirnaty 30mcg), age 6 years (Spikevax), age 5-11 years (Comirnaty 10mcg); from age 12 years in those who have previously received a primary vaccination course (Comirnaty Original/Omicron BA.1 and BA.4-5).
Dose, Adult: Comirnaty, 30mcg/dose, from age 12 years, 2-dose course (0.3mL each); second dose 3 weeks after first. For injection, the 30mcg/dose concentrate for dispersion (after dilution) and dispersion are considered interchangeable.
Comirnaty Original/Omicron variants (BA.1 or BA.4-5) 15mcg/15mcg/dose, a dose of 0.3mL IM at least 3 months after last prior dose of COVID-19 vaccine.
Spikevax (0.2mg/mL), from age 12 years, 2-dose course (0.5mL each); second dose 28 days after first.
Booster (Comirnaty 30mcg/dose, Spikevax), from age 12 years, may admin a booster at least 3 months after second dose (from age 18 years, Comirnaty 30mcg/dose may be given as booster dose to those who have received a primary course of another mRNA or adenoviral vector vaccine); severely immunocompromised, from age 12 years (Comirnaty 30mcg/dose, Spikevax) or from age 5 years (Comirnaty 10mcg/dose), may admin booster at least 28 days after second dose.
Admin, IM injection, deltoid muscle of upper arm. NOT for IV, SC or intradermal injection.
Dose, Elderly: Age 65 years and older, no dose adjustment.
Dose, Child: Comirnaty (10mcg/dose), age 5-11 years, 2-dose course (0.2mL each); second dose 3 weeks after first.
Spikevax (0.2mg/mL), age 6-11 years, 2-dose course (0.25mL each containing 50mcg i.e. half primary dose for age 12 years and older); second dose 28 days after first.
Booster (third dose), Comirnaty 10mcg/dose, age 5-11 years OR Spikevax, from age 12 years, may admin a booster at least 6 months (Comirnaty) or 3 months (Spikevax) after primary course. Severely immunocompromised, from age 12 years (Comirnaty 30mcg/dose) or age 5-11 years (Comirnaty 10mcg/dose) OR age 6-11 years (Spikevax 0.25mL or 50mcg), may admin booster at least 28 days after second dose.
From age 12 years, Comirnaty (30mcg/dose), Spikevax, see Adult.
Admin, see Adult.
Under 6 years (Spikevax), under 5 years (Comirnaty), safety and efficacy not established.
Interaction(s): Effect of Other Drugs on COVID-19 mRNA Vaccines: No interactions studies performed. High-dose quadrivalent influenza vaccine can be co-admin with Spikevax.
Special Precautions: Individuals vaccinated may not be fully protected until 7 days (Comirnaty) or 14 days (Spikevax) after the second dose. Duration of protection is still being determined by ongoing clinical trials.
Myocarditis, pericarditis risk (very rare); usually within 14 days post-vaccination; more often (after second vaccine, in younger men); risk seems lower in children aged 5-11 years than those aged 12-17 years. Ensure vaccinees understand to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis e.g. (acute and persisting) chest pain, shortness of breath, palpitations (after vaccination). Erythema multiforme (red spots/patches on the skin) and unusual or decreased feeling in the skin.
Anxiety-related reactions, concurrent illness, thrombocytopenia, coagulation disorders, see Class Effects.
Pregnancy, Lactation: Can be used.
Adverse Reaction(s): Summary, most frequent, all brands, injection site pain, fatigue, headache, myalgia, chills, arthralgia; pyrexia, injection site swelling (except Comirnaty BA.1 or BA.4-5). Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
Comirnaty: Safety profile in adolescents aged 5-15 years was similar to age 16 years and older, most frequent, fatigue, headache, myalgia, chills, arthralgia, pyrexia. Age 18 years and older, after booster (third) dose, most frequent, injection site pain, fatigue, headache, myalgia, chills, arthralgia.
Spikevax: Additional, nausea and vomiting, axillary swelling and/or tenderness, fever, injection site redness. Overall, higher incidence of some adverse reactions in younger age groups e.g. axillary swelling or tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea and/or vomiting and fever was higher in ages 18 to under 65 years than in age 65 years and older. Local and systemic reactions were more frequently reported after Dose 2 than after Dose 1.
▼Comirnaty COVID-19 Vaccine, Paediatric (Pfizer)
30mcg/0.3mL per dose (concentrate), dispersion for injection (concentrate), tozinameran COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Tozinameran [single-stranded mRNA encoding SARS-CoV-2 viral spike (S) protein]. White (off-white) frozen dispersion (conc); must be diluted before use. NOTE: Multidose vial with purple cap.
Excipient(s): Essentially sodium- and potassium-free.
Store: Unopened vial, frozen: 18 months at -90 to -60 deg. When stored at -90 to -60 deg C, can thaw 195-vial packs to 2-8 deg C for 3 hours or individual vials to room temperature (up to 30 deg ) for 30 minutes. Unopened vial, thawed: 1 month at 2-8 deg within 18-month shelf life. Before using: Up to 2 hours up to 30 deg C. Thawed vial, do not refreeze; can handle in room light.
30mcg/0.3mL per dose dispersion for injection, tozinameran COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Tozinameran, as above. White (off-white) frozen dispersion; do not dilute before use. NOTE: Multidose vial with grey cap.
Store: Unopened vial, frozen: 18 months at -90 to -60 deg C. When stored at -90 to -60 deg C, can thaw 10-vial packs 2-8 deg C for 6 hours or individual vials to room temp (up to 30 deg) for 30 minutes. Original pack (light). Unopened vial, thawed: 10 weeks, storage and transport at 2-8 deg C within 18-month shelf-life. Before using: Up to 12 hours between 8-30 deg C. Thawed vial, do not refreeze; can handle in room light.
10mcg/0.2mL dose (paediatric) dispersion for injection (concentrate) paediatric, tozinameran COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Tozinameran, as above. White (off-white) frozen dispersion (conc); must be diluted before use. NOTE: Multidose vial with orange cap.
Store: Unopened vial, frozen: 18 months at -90 to -60 deg C. When stored at -90 to -60 deg C, can thaw 10-vial packs 2-8 deg C for 4 hours or individual vials to room temp (up to 30 deg) for 30 minutes. Original pack (light). Unopened vial, thawed: 10 weeks, store and transport at 2-8 deg C within 18-month shelf-life. Before using: Up to 12 hours between 8-30 deg C. Thawed vial, do not refreeze; can handle in room light.
▼Comirnaty Original/Omicron BA.1 COVID-19 Vaccine (Pfizer)
15mcg/15mcg per dose, dispersion for injection, tozinameran 15mcg, riltozinameran 15mcg per 0.3mL dose COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Single-stranded mRNA encoding SARS-CoV-2 viral spike (S) protein, original (tozinameran) and Omicron BA.1 (riltozinameran). White (off-white) frozen dispersion; do not dilute before use. NOTE: Multidose vial with grey cap.
Store: Unopened vial, frozen: 18 months frozen at -90 to -60 deg C. When stored at -90 to -60 deg, can thaw 10-vial packs to 2-8 deg C for 6 hours or individual vials to room temperature (up to 30 deg C) for 30 minutes. Unopened vial, thawed: 10 weeks storage and transport at 2-8 deg C within 18-month shelf life. Before using: Up to 12 hours between 8-30 deg C. Thawed vial, do not refreeze; can be handled in room light conditions.
▼ Comirnaty Original/Omicron BA.4-5 COVID-19 Vaccine (Pfizer)
15mcg/15mcg per dose, dispersion for injection, tozinameran 15mcg, famtozinameran 15mcg per 0.3mL dose COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Single-stranded mRNA encoding SARS-CoV-2 viral spike (S) protein, original (tozinameran) and Omicron BA.4-5 (famtozinameran). White (off-white) frozen dispersion; do not dilute before use. NOTE: Multidose vial with grey cap.
Store: Unopened vial, frozen: 18 months frozen at -90 to -60 deg C. When stored at -90 to -60 deg, can thaw 10-vial packs to 2-8 deg C for 6 hours or individual vials to room temperature (up to 30 deg C) for 30 minutes. Unopened vial, thawed: 10 weeks storage and transport at 2-8 deg C within 18-month shelf life. Before using, up to 12 hours between 8-30 deg C. Thawed vial, do not refreeze; can be handled in room light conditions.
▼ Spikevax COVID-19 Vaccine (Moderna)
100mcg per dose, dispersion for injection, elasomeran 100mcg/0.5mL dose COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Single-stranded mRNA (in vitro transcription) encoding SARS-CoV-2 viral spike (S) protein. White (off-white) dispersion. Excipient(s): Essentially sodium-free. Store: Freeze at -50 to -15 deg C. Original pack (light). Can transport as thawed vaccine in liquid state (up to 12 hours at 2-8 degrees C). Do not refreeze.
ATC Code: J07BX03.
Indication(s): Active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus from age 18 years (JCOVDEN, Vaxzevria) OR age 12 years (Nuvaxovid).
Dose, Adult: From age 18 years, JCOVDEN, admin as a single dose (0.5mL). Booster (second dose), of 0.5 mL may be admin IM at least 2 months after the primary vaccination; may admin as a heterologous booster dose completion of primary vaccination with an approved mRNA COVID-19 vaccine (dose interval same as for vaccine used in primary schedule).
From age 18 years, Vaxzevria, admin as a 2-dose course (0.5mL each), between 4 and 12 weeks (28-84 days) apart. Booster (third dose) of 0.5mL may be admin at least 3 months after primary vaccination; may be admin to individuals who completed the primary vaccination course with Vaxzevria or an mRNA COVID-19 vaccine.
From age 12 years, Nuvaxovid, admin as a 2-dose course (0.5mL each), 3 weeks after first dose. From age 18 years, booster (third dose), of 0.5mL may be admin IM at approx. 6 months after the primary vaccination; may admin as a heterologous booster dose completion of primary vaccination with an approved mRNA COVID-19 vaccine or adenoviral vector vaccine (dose interval same as for vaccine used in primary schedule).
Admin, IM injection ONLY, preferably deltoid muscle of upper arm. NOT for IV, SC or intradermal injection.
Dose, Elderly: No dose adjustment.
Dose, Child: Age 18 years and older (JCOVDEN, Vaxzevria) OR 12 years and older (Nuvaxovid), as for Adult. Under 18 years (JCOVDEN, Vaxzevria) OR under 12 years (Nuvaxovid), safety and efficacy not established.
Contraindications: Thrombosis with thrombocytopenia syndrome (TTS) following vaccination; previous episodes of capillary leak syndrome (CLS) (JCOVDEN, Vaxzevria).
Interactions: Effect of Other Drugs on COVID-19 rDNA Vaccines: No interaction studies performed. The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was co-admin with inactivated influenza vaccine (clinical significance unknown).
Special Precautions: Individuals vaccinated may not be fully protected until 14 days after single dose vaccination (JCOVDEN) OR 15 days (Vaxzevria) OR 7 days (Nuvaxovid) after the second dose. Duration of protection is still being determined by ongoing clinical trials.
JCOVDEN, Vaxzevria, thrombosis with thrombocytopenia syndrome (rare), some cases with bleeding, post-vaccination, including severe cases presenting as venous thrombosis at unusual sites e.g. cerebral venous sinus thrombosis, splanchnic vein thrombosis and arterial thrombosis, with thrombocytopenia (some cases fatal). Majority occurred within first 3 weeks post-vaccination, mostly in women (both brands) under age 60 years (JCOVDEN). Thrombosis with thrombocytopenia requires specialised clinical management; consult guidance and/or consult specialists e.g. haematologists, coagulation specialists to diagnose and treat.
JCOVDEN, Vaxzevria, very rarely reported, Guillain-Barré syndrome (GBS) following vaccination. H/care professionals to be alert for GBS signs and symptoms; ensure correct diagnosis (or rule out other causes) and initiate adequate supportive care and treatment. Capillary leak syndrome (CLS) in first days post-vaccination; some cases fatal. CLS characterised by acute episodes of oedema (mainly limbs), hypotension, haemoconcentration, hypoalbuminaemia. Acute CLS episode following vaccination requires prompt recognition, treatment. Intensive supportive therapy usually needed. Do not vaccinate with known CLS history.
Anxiety-related reactions, concurrent illness, thrombocytopenia, coagulation disorders, see Class Effects.
Pregnancy, Lactation: Weigh risk/benefit. Unknown if excreted in human milk.
Adverse Reactions: Summary, most frequent (all brands), injection site pain, headache, fatigue, myalgia, nausea. Reactogenicity was generally milder and reported less frequently in older adults.
Additional adverse reactions, JCOVDEN, pyrexia; most reactions were mild to moderate and of short duration (1-2 days). Nuvaxovid, injection site tenderness, arthralgia, malaise, vomiting; reactions were usually mild to moderate, of duration under 2 days (local events) or 1 day (systemic events). Vaxzevria, pyrexia, injection site tenderness, malaise, chills, arthralgia; most reactions were mild to moderate and usually resolved within a few days; those reported after the second dose were milder and reported less frequently.
▼ JCOVDEN COVID-19 Vaccine (Janssen)
Injection, COVID-19 rDNA 0.5mL (one dose). Recombinant DNA technology. Adenovirus type 26 encoding SARS-CoV-2 Spike (S) glycoprotein (Ad26.COV2-S). Colourless (slightly-yellow) clear (very-opalescent). Excipient(s): Essentially sodium-free; ethanol 2mg/0.5mL. Store, Transport: Freeze (-25 to -15 deg). Can be refrigerated (2-8 deg C) for single period of up to 11 months. Do not re-freeze. Vials in outer carton (light). In-Use (not for storage or transport): Unopened, 9-25 deg C (max. 12 hours).
▼ Nuvaxovid COVID-19 Vaccine (Novavax)
Dispersion for injection, COVID-19 rDNA 0.5mL (one dose). SARS-CoV-2 spike protein adjuvanted with Matrix-M (Fraction A and C of Quillaja saponaria Molina extract). Recombinant DNA technology using aculovirus expression system in insect cell line (Sf9 cells of Spodoptera frugiperda species). Colourless (slightly yellow) clear (mildly opalescent). Excipient(s): Essentially sodium- and potassium-free. Store: Refrigerate (2-8 deg C). Do not freeze. Outer container (light). In-Use (not for storage or transport): Unopened, under 25 deg C (max. 12 hours).
▼ Vaxzevria COVID-19 Vaccine (AstraZeneca)
Injection, COVID-19 vaccine 0.5mL (one dose). Recombinant DNA technology. Chimpanzee Adenovirus encoding SARS-CoV-2 Spike (S) glycoprotein (ChAdOx1-S). Colourless (slightly-brown) clear (slightly-opaque). Excipient(s): Essentially sodium-free; ethanol 2mg/0.5mL. Store: Refrigerate (2-8 deg C). Do not freeze. Vials in outer carton (light).
The EMA published its final safety update on COVID-19 vaccines in December 2022. The EMA continues to monitor and assess safety data on COVID-19 vaccines as it does for all medicines authorised in the EU.
▼Comirnaty COVID-19 Vaccine (Pfizer)
Safety Update (EMA 08 December 2022): Based on continuous safety monitoring and assessments, there are currently no updates to the product information of Comirnaty.
NOTE: About 685 million doses of Comirnaty in adults including 57.3 million doses of Comirnaty in children and adolescents (below 18 years of age) were administered in the EU/EEA from authorisation to 13 November 2022. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)]. Additionally, about 16.1 million doses of adapted bivalent Comirnaty vaccines, including about 52,400 doses in adolescents (below 18 years of age), have been administered.
▼ Spikevax COVID-19 Vaccine (previously Moderna COVID-19 Vaccine) (Moderna)
Safety Update (EMA 08 December 2022): Based on continuous safety monitoring and assessments, there are currently no updates to the product information of Spikevax.
NOTE: About 161 million doses of Spikevax in adults including 3.1 million doses of Spikevax in children and adolescents (below 18 years of age) were administered in the EU/EEA from authorisation to 13 November 2022. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)]. Additionally, over 317,800 doses of adapted Spikevax vaccines (bivalent) have also been administered including about 200 doses in children and adolescents (below 18 years of age).
▼ JCOVDEN COVID-19 Vaccine (formerly COVID-19 Vaccine Janssen) (Janssen-Cilag/Johnson & Johnson)
Safety Update (EMA 08 December 2022): Based on continuous safety monitoring and assessments, there are currently no updates to the product information of Jcovden.
NOTE: About 18.6 million doses of Jcovden were administered to adults in the EU/EEA from authorisation to 13 November 2022. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)].
▼Nuvaxovid COVID-19 Vaccine (Novavax)
Safety Update (EMA 08 December 2022): Based on continuous safety monitoring and assessments, there are currently no updates to the product information of Nuvaxovid.
NOTE: About 361,000 doses of Nuvaxovid were administered to adults in the EU/EEA from authorisation to 13 November 2022. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)].
▼Vaxzevria COVID-19 Vaccine (AstraZeneca)
Safety Update (EMA 08 December 2022): Based on continuous safety monitoring and assessments, there are currently no updates to the product information of Vaxzevria.
NOTE: About 68.8 million doses of Vaxzevria were administered to adults in the EU/EEA from authorisation to 13 November 2022. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)].
The EMA published its final safety update on COVID-19 vaccines in December 2022. The EMA continues to monitor and assess safety data on COVID-19 vaccines as it does for all medicines authorised in the EU.
- Menstrual Bleeding: For Comirnaty and Spikevax, an update to the product information has been recommended to add heavy menstrual bleeding as a side effect.
- Urticaria: For Spikevax, a further update to the product information has been recommended to include urticaria as an uncommon side effect (i.e., occurring in less than 1 in 100 persons).
- Corneal graft rejection (CGR): Available evidence does not support a causal relationship of CGR with Comirnaty, Spikevax or Vaxzevria. [08 September 2022].
- Myocarditis and pericarditis: Update to the product information. In December 2021, PRAC concluded that the risk of myocarditis and pericarditis (inflammatory conditions of the heart) after vaccination with Comirnaty is highest in young males, especially after the second vaccination (see safety update of December 2021). Overall, there is a very rare risk of myocarditis and pericarditis following vaccination with Comirnaty regardless of dose. [08 September 2022].
PRAC has continued monitoring this risk and assessed recent data, including a US study that analysed data from three safety monitoring systems. Based on this new information, PRAC has recommended an update to the EU product information to state that the risk of myocarditis and pericarditis seems lower in children aged 5-11 years than in those aged 12-17 years. The overall frequency category of myocarditis/pericarditis is already described in the product information as very rare (i.e. occurring in less than 1 in 10,000 persons vaccinated). - Vulval ulceration: Assessment started. A very small number of cases of vulval ulceration will be assessed to determine whether they may have been caused by Comirnaty. Vulval ulcerations are usually self-limiting sores on the outer parts of the female genitals. Reported cases concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. [08 September 2022].
- Histiocytic necrotising lymphadenitis: Monitored within routine safety surveillance. A very small number of cases of histiocytic necrotising lymphadenitis (HNL) will be further monitored and assessed within the regular safety surveillance of Comirnaty. HNL is a condition involving swollen lymph nodes, mild fever and night sweats, and is usually transient and self-limiting. Reported cases concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. [08 September 2022].
- Myocardial infarction, pulmonary embolism and thrombosis: Available evidence does not support a causal relationships with Vaxzevria. [17 June 2022].
- Myocarditis and pericarditis: An assessment of myocarditis and pericarditis (inflammatory conditions of the heart) has been started, to establish whether these may be side effects of Nuvaxovid. [17 June 2022]. In July 2022, it was noted that the Australian Therapeutic Goods Administration (TGA) recently added pericarditis (inflammation of lining around the heart) to the product information as a side effect of unknown frequency. Only a small number of myocarditis and/or pericarditis cases have been reported spontaneously with use of Nuvaxovid in the EU (5 EU/EEA cases reported by 31 May 2022 from about 210,000 vaccine doses administered in the EU/EEA by 15 May 20223). Generally, cases reported spontaneously by a patient or healthcare professional concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. Additional information and further data has been requested from the marketing authorisation holder to finalise assessment of myocarditis and pericarditis.
Symptoms of myocarditis and pericarditis can vary but often include breathlessness, a forceful heartbeat that may be irregular (palpitations), and chest pain. These conditions can have various causes, including viral infection as a common cause and, less commonly, autoimmune disorders. Persons experiencing the above symptoms should seek immediate medical attention to obtain treatment. - Myocardial infarction: Available evidence does not support a causal relationship of myocardial infarction with Jcovden. [17 June 2022].
- Amenorrhoea and heavy menstrual bleeding: Available evidence does not support a causal relationship of amenorrhoea with Comirnaty and Spikevax; the assessment of heavy menstrual bleeding is ongoing. [17 June 2022].
- Auto-immune hepatitis (AIH): No evidence for a causal relationship with Comirnaty or Spikevax. An assessment of whether vaccination with Comirnaty or Spikevax can cause auto-immune hepatitis (AIH) has been completed. EMA-PRAC has concluded that the currently available evidence does not support a causal association between the vaccines and this condition. [12 May 2022].
- Corneal graft rejection (CGR): Assessment started for Comirnaty, Spikevax and Vaxzevria. EMA-PRAC started an assessment of corneal graft rejection (CGR) to establish whether it may be a side effect of COVID-19 vaccines (Comirnaty, Spikevax and Vaxzevria). CGR occurs when the body’s immune system mistakenly attacks the donor cornea (the transparent layer in front of the eye) that has replaced a damaged or diseased one. The assessment follows a very small number of cases of CGR reported after vaccination with Comirnaty, Spikevax and Vaxzevria in the medical literature and EudraVigilance. Reported cases concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. [12 May 2022].
The EMA published its final safety update on COVID-19 vaccines in December 2022. The EMA continues to monitor and assess safety data on COVID-19 vaccines as it does for all medicines authorised in the EU.
▼Comirnaty COVID-19 Vaccine (Pfizer)
Safety Update (EMA 08 December 2022): Based on continuous safety monitoring and assessments, there are currently no updates to the product information of Comirnaty.
Safety Update (EMA 10 November 2022): PRAC has recommended that heavy menstrual bleeding should be added to the Comirnaty product information as a side effect of unknown frequency. The conclusion was based on evidence including cases reported during clinical trials, observational studies, intensified post-marketing surveillance activities and spontaneously reported cases by patients and healthcare professionals, including from European countries, present in EudraVigilance. The assessment included almost 9,000 worldwide reports of heavy menstrual bleeding with either Comirnaty or Spikevax (both mRNA vaccines). The frequency category assigned is ‘not known’, as it is generally difficult to robustly estimate side effect frequencies from spontaneously reported cases of suspected side effects. In general, cases reported spontaneously by a patient or healthcare professional concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. Heavy menstrual bleeding (heavy periods) may be defined as bleeding characterised by an increased volume and/or duration which interferes with the person’s physical, social, emotional and material quality of life. Cases of heavy menstrual bleeding have been reported after the first, second and booster doses of Comirnaty. A small number of cases involved positive rechallenge (where heavy menstrual bleeding was seen after the initial vaccination and occurred again after a second dose). A positive rechallenge may indicate that a medicine may have caused the side effect in question. The available data reviewed involved cases that were mostly non-serious and temporary. After reviewing the data, the Committee concluded that there is at least a reasonable possibility that heavy menstrual bleeding is causally associated with Comirnaty and therefore recommended updating the product information. There is no evidence to suggest that menstrual changes experienced by some people following vaccination have any impact on fertility. With regard to the effects of COVID-19 vaccination on pregnancy in general, several studies involving around 65,000 pregnancies at different stages did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination.
Safety Update (EMA 06 October 2022): There are no safety updates.
Safety Update (EMA 08 September 2022): The EMA Pharmacovigilance Risk Assessment Committee (PRAC) has recommended an update to the
EU product information to state that the risk of myocarditis and pericarditis seems lower in children aged 5-11 years than in those aged 12-17 years. The overall frequency category of myocarditis/pericarditis is already described in the product information as very rare (i.e. occurring in less than 1 in 10,000 persons vaccinated).
EU product information to state that the risk of myocarditis and pericarditis seems lower in children aged 5-11 years than in those aged 12-17 years. The overall frequency category of myocarditis/pericarditis is already described in the product information as very rare (i.e. occurring in less than 1 in 10,000 persons vaccinated).
Safety Update (EMA 14 July 2022, updated 03 August 2022): There are currently no safety updates.
Safety Update (EMA 17 June 2022): There are currently no safety updates.
Safety Update (EMA 12 May 2022): There are currently no safety updates.
Safety Update (EMA 12 May 2022): No updates to the product information currently recommended. Name changed from COVID-19 Vaccine Janssen to JCOVDEN COVID-19 Vaccine.
Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
Safety Update (EMA 17 March 2022): An assessment of whether vaccination with Comirnaty can cause capillary leak syndrome (CLS) has been completed. The EMA Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that there are currently insufficient data to support an update of the product information.
Safety Update (EMA 17 February 2022): The product information of the mRNA vaccines will be updated to reflect the accumulating evidence that they can be used during pregnancy and breastfeeding. PRAC started a further assessment of menstrual disorders following use of mRNA vaccines with a focus on heavy menstrual bleeding and the absence of menstruation (amenorrhoea).
Safety Update (EMA 20 January 2022): An assessment of whether vaccination can cause capillary leak syndrome (leakage of fluid from blood vessels) is ongoing.
Safety Update (EMA 09 December 2021): The overall frequency of the side effects myocarditis and pericarditis has been determined to be very rare. The risk has been confirmed to be highest in younger males; estimates of the risk will be included in the product information for Comirnaty.
Safety Update (EMA 11 November 2021): There are no updates to the product information. Further assessment of myocarditis and pericarditis is ongoing. There is currently insufficient evidence of a possible link between Comirnaty and very rare cases of multisystem inflammatory syndrome (MIS).
Safety Update (EMA 06 October 2021): Erythema multiforme (red spots/patches on the skin) and unusual or decreased feeling in the skin will be added to the product information as side effects.
Safety Update (EMA 08 September 2021): No further updates to the product information are currently recommended.
Safety Update (EMA 11 August 2021): No further updates to the product information are currently recommended.
Safety Update (EMA 14 July 2021): Inflammation of the heart muscle (myocarditis) or membrane (pericarditis) may occur in a small number of people after vaccination with Comirnaty. The product information will be updated. Comirnaty is effective in preventing COVID-19.
Safety Update (EMA 18 June 2021): Reports of inflammation of the heart muscle (myocarditis) and membrane (pericarditis) in a small number of people after vaccination continue to be assessed under an accelerated timetable. There are no updates to the product information. Comirnaty is effective in preventing COVID-19.
More Flexible Storage Conditions (EMA 17 May 2021): The EMA human medicines committee (CHMP) has recommended a change to the approved storage conditions that will facilitate the handling of the vaccine in vaccination centres across the European Union (EU). The changes described will be included in the publicly available information on and will be implemented by the MAH in updated product labelling. Users are reminded to always refer to the label and package leaflet of the supplied product for the correct storage information. This change extends the approved storage period of the unopened thawed vial at 2-8 deg C (i.e. in a normal fridge after taking out of deep-freeze conditions) from five days to one month (31 days). The change was approved following assessment of additional stability study data submitted to EMA by the marketing authorisation holder (MAH). Increased flexibility in the storage and handling of the vaccine is expected to have a significant impact on planning and logistics of the vaccine roll-out in EU Member States.
Safety Update (EMA 11 May 2021): Swelling of the face in people who have had a dermal filler injection will be added to the product information of Comirnaty as a side effect. Case reports of inflammation of the heart muscle and membrane will be further assessed.
Adolescent Indication (EMA 02 May 2021): Indication extended to include adolescents from age 12 years.
Safety Update (EMA 14 April 2021): Specific allergic skin reactions will be added to the product information.
Safety Update (EMA 29 March 2021): Swelling of the vaccinated limb usually recovers by itself.
Safety Update (EMA 04 March 2021): Diarrhoea and vomiting after vaccination have been identified as new side effects.
Safety Update (EMA 28 January 2021): Reports of suspected severe allergic reaction have not identified new aspects regarding the nature of this known side effect. No specific safety concern has been identified for vaccine use in frail elderly individuals.
▼ Spikevax COVID-19 Vaccine (previously Moderna COVID-19 Vaccine) (Moderna)
Safety Update (EMA 08 December 2022): Based on continuous safety monitoring and assessments, there are currently no updates to the product information of Spikevax.
Safety Update (EMA 10 November 2022): PRAC has recommended that heavy menstrual bleeding should be added to the Comirnaty product information as a side effect of unknown frequency. The conclusion was based on evidence including cases reported during clinical trials, observational studies, intensified post-marketing surveillance activities and spontaneously reported cases by patients and healthcare professionals, including from European countries, present in EudraVigilance. The assessment included almost 9,000 worldwide reports of heavy menstrual bleeding with either Comirnaty or Spikevax (both mRNA vaccines). The frequency category assigned is ‘not known’, as it is generally difficult to robustly estimate side effect frequencies from spontaneously reported cases of suspected side effects. In general, cases reported spontaneously by a patient or healthcare professional concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. Heavy menstrual bleeding (heavy periods) may be defined as bleeding characterised by an increased volume and/or duration which interferes with the person’s physical, social, emotional and material quality of life. Cases of heavy menstrual bleeding have been reported after the first, second and booster doses of Comirnaty. A small number of cases involved positive rechallenge (where heavy menstrual bleeding was seen after the initial vaccination and occurred again after a second dose). A positive rechallenge may indicate that a medicine may have caused the side effect in question.The available data reviewed involved cases that were mostly non-serious and temporary. After reviewing the data, the Committee concluded that there is at least a reasonable possibility that heavy menstrual bleeding is causally associated with Spikevax and therefore recommended updating the product information. There is no evidence to suggest that menstrual changes experienced by some people following vaccination have any impact on fertility. With regard to the effects of COVID-19 vaccination on pregnancy in general, several studies involving around 65,000 pregnancies at different stages did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination.
The PRAC concluded an assessment of the hypersensitivity reaction urticaria (hives [raised, red and itchy skin rash]) with Spikevax. After reviewing the data, the Committee concluded that there is at least a reasonable possibility that urticaria is causally associated with Spikevax and therefore recommended updating the product information. The Committee recommended that urticaria should be added to the product information as a side effect of uncommon frequency (occurring in less than 1 in 100 people). Urticaria has been observed with either acute onset (within a few days after vaccination) or delayed onset (up to approximately two weeks after vaccination).
Safety Update (EMA 06 October 2022): Assessment ongoing. An assessment of the potential hypersensitivity reaction urticaria (hives [raised, red and itchy skin rash]) with Spikevax remains ongoing.
Safety Update (EMA 08 September 2022): PRAC assessment concluded that the available evidence does not support a causal relationship of corneal graft rejection with Spikevax. Update to the product information. PRAC concluded that the risk of myocarditis and pericarditis (inflammatory conditions of the heart) after vaccination with Spikevax is highest in young males, especially after the second vaccination. The product information of Spikevax has been updated to reflect that the risk profile for myocarditis and pericarditis seems to be similar after the second and the third dose. The overall frequency category of myocarditis/pericarditis is already described in the product information as very rare (i.e. occurring in less than 1 in 10,000 vaccinated persons).
Safety Update (EMA 14 July 2022, updated 03 August 2022): Extensive swelling of the vaccinated limb will be included in the EU product information as a side effect of Spikevax. The frequency category will be ‘not known’, as it is generally difficult to robustly estimate side effect frequencies from spontaneously reported cases of suspected side effects.
Cases of extensive swelling of the vaccinated limb have been reported spontaneously with use of Spikevax (more than 3,200 EU/EEA cases reported to EudraVigilance (see section 2) by 2 May 2022). Generally, cases reported spontaneously by a patient or healthcare professional concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. In general, extensive swelling of the vaccinated limb is a condition that does not require treatment and resolves after some days.
Cases of extensive swelling of the vaccinated limb have been reported spontaneously with use of Spikevax (more than 3,200 EU/EEA cases reported to EudraVigilance (see section 2) by 2 May 2022). Generally, cases reported spontaneously by a patient or healthcare professional concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. In general, extensive swelling of the vaccinated limb is a condition that does not require treatment and resolves after some days.
Safety Update (EMA 17 June 2022): There are currently no safety updates.
Safety Update (EMA 12 May 2022): There are currently no safety updates.
Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
Safety Update (EMA 17 March 2022): The EMA Pharmacovigilance Risk Assessment Committee (PRAC) recommends updating the product information with a warning to reflect the potential of flare-ups of capillary leak syndrome (leakage of fluid from blood vessels) following vaccination with Spikevax, in patients who have a medical history of this extremely rare condition.
Safety Update (EMA 17 February 2022): The product information of the mRNA vaccines will be updated to reflect the accumulating evidence that they can be used during pregnancy and breastfeeding. PRAC started a further assessment of menstrual disorders following use of mRNA vaccines with a focus on heavy menstrual bleeding and the absence of menstruation (amenorrhoea).
Safety Update (EMA 20 January 2022): The product information will be updated to include paraesthesia (unusual feeling in the skin) as a rare side effect.
Safety Update (EMA 09 December 2021): The overall frequency of the side effects myocarditis and pericarditis has been determined to be very rare. The risk has been confirmed to be highest in younger males; estimates of the risk will be included in the product information for Spikevax.
Safety Update (EMA 11 November 2021): There are no updates to the product information. Further assessment of myocarditis and pericarditis is ongoing. There is currently insufficient evidence of a possible link between Spikevax and very rare cases of multisystem inflammatory syndrome (MIS).
Safety Update (EMA 06 October 2021): Erythema multiforme (red spots/patches on the skin) will be added to the product information as a side effect.
Safety Update (EMA 08 September 2021): No further updates to the product information are currently recommended.
Safety Update (EMA 11 August 2021): No further updates to the product information are currently recommended.
Safety Update (EMA 14 July 2021): Inflammation of the heart muscle (myocarditis) or membrane (pericarditis) may occur in a small number of people after vaccination with Spikevax. The product information will be updated. Spikevax is effective in preventing COVID-19.
Safety Update (EMA 18 June 2021): Reports of inflammation of the heart muscle (myocarditis) and membrane (pericarditis) in a small number of people after vaccination continue to be assessed under an accelerated timetable. There are no updates to the product information. Spikevax (previously Moderna COVID-19 Vaccine) is effective in preventing COVID-19.
Safety Update (EMA 11 May 2021): Diarrhoea and delayed injection site reactions will be added as side effects to the product information. Case reports of inflammation of the heart muscle and membrane will be further assessed.
Safety Update (EMA 05 February 2021): This update presents the assessment of an investigation of reports of suspected severe allergic reaction coming from a single vaccination site in the United States. The assessment of these reports has not identified new aspects regarding the nature of this known side effect.
▼ JCOVDEN COVID-19 Vaccine (formerly COVID-19 Vaccine Janssen) (Janssen-Cilag/Johnson & Johnson)
Safety Update (EMA 08 December 2022): Based on continuous safety monitoring and assessments, there are currently no updates to the product information of Jcovden.
Safety Update (EMA 10 November 2022): There are no safety updates.
Safety Update (EMA 06 October 2022): PRAC concluded an assessment for Jcovden with a recommendation to update the product information by adding facial paralysis (temporary facial drooping, usually one-sided), including Bell’s palsy, as a side effect. Based on clinical trial data, this side effect was considered to be rare (i.e. occurring in less than 1 in 1,000 persons).
Safety Update (EMA 08 September 2022): There are no safety updates.
Safety Update (EMA 14 July 2022, updated 03 August 2022): There are currently no safety updates.
Safety Update (EMA 17 June 2022): There are currently no safety updates.
Safety Update (EMA 12 May 2022): There are currently no safety updates. Name changed from COVID-19 Vaccine Janssen to JCOVDEN COVID-19 Vaccine.
Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
Safety Update (EMA 17 March 2022): The EMA Pharmacovigilance Risk Assessment Committee (PRAC) recommends updating the product information to include cutaneous small vessel vasculitis (inflammation of blood vessels in the skin which may result in a rash, pointed or flat, red spots under the skin’s surface and bruising) should be added to the product information of COVID-19 Vaccine Janssen as a possible side effect of unknown frequency. Small vessel vasculitis can be caused by viral or bacterial infections as well as by medicines and vaccines. Generally, manifestations of the disease spontaneously resolve over time with appropriate supportive care.
Safety Update (EMA 17 February 2022): No safety updates.
Safety Update (EMA 20 January 2022): The product information will be updated to add transverse myelitis (inflammation in the spinal cord) as a side effect. Information on the known side effect of thrombosis with thrombocytopenia syndrome (TTS; blood clots with low blood platelets) will be updated in the product information.
Safety Update (EMA 09 December 2021): Cutaneous small vessel vasculitis (inflammation of blood vessels in the skin) was recommended by PRAC to be added as a side effect to the product information of COVID-19 Vaccine Janssen.
Safety Update (EMA 11 November 2021): There are no updates to the product information. There is currently insufficient evidence of a possible link between COVID-19 Vaccine Janssen and either multisystem inflammatory syndrome (MIS) or menstrual disorders.
Safety Update (EMA 06 October 2021): Venous thromboembolism (VTE) (blood clotting in the veins) and immune thrombocytopenia (ITP), (and autoimmune condition with low blood platelet levels) will be added to the product information as side effects, together with warnings and advice.
Transverse myelitis (inflammation in parts of the spinal cord) was recommended by the EMA Pharmacovigilance Risk Assessment Committee (PRAC) to be added to the product information as a side effect of COVID-19 Vaccine Janssen.
Transverse myelitis (inflammation in parts of the spinal cord) was recommended by the EMA Pharmacovigilance Risk Assessment Committee (PRAC) to be added to the product information as a side effect of COVID-19 Vaccine Janssen.
Safety Update (EMA 08 September 2021): Recommended product information update to include swollen lymph nodes, unusual or decreased feeling in the skin, tinnitus, diarrhoea and vomiting as side effects.
Safety Update (EMA 11 August 2021): Guillain-Barré syndrome has been added to the product information as a very rare side effect. Recommended to update the product information to include immune thrombocytopenia, dizziness and tinnitus as side effects.
Safety Update (EMA 14 July 2021): People who have previously had capillary leak syndrome must not receive COVID-19 Vaccine Janssen. Capillary leak syndrome may also occur as a side effect of COVID-19 Vaccine Janssen. The product information will be updated. COVID-19 Vaccine Janssen is effective in preventing COVID-19.
Safety Update (EMA 18 June 2021): There are no updates to the product information. COVID-19 Vaccine Janssen is effective in preventing COVID-19.
Safety Update (EMA 11 May 2021): Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with COVID-19 Vaccine Janssen should be actively investigated for signs of thrombosis; similarly, individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia
Safety Update (EMA 27 April 2021): Unusual blood clots in combination with low blood platelet levels have been identified as a very rare side effect of COVID-19 Vaccine Janssen. Vaccinated persons should seek immediate medical attention if symptoms of blood clotting occur, to help avoid complications.
▼Nuvaxovid COVID-19 Vaccine (Novavax)
Safety Update (EMA 08 December 2022): Based on continuous safety monitoring and assessments, there are currently no updates to the product information of Nuvaxovid.
Safety Update (EMA 10 November 2022): There are no safety updates.
Safety Update (EMA 06 October 2022): There are no safety updates.
Safety Update (EMA 08 September 2022): There are no safety updates.
Safety Update (EMA 14 July 2022, updated 03 August 2022): Anaphylaxis (severe allergic reaction) together with an update of the existing advice for managing risk of anaphylaxis and paraesthesia (unusual feeling in the skin, such as tingling or a crawling sensation) and hypoaesthesia (decreased feeling or sensitivity, especially in the skin) will be included in the EU product information as a side effect of Nuvaxovid. The frequency category will be ‘not known’, as it is generally difficult to robustly estimate side effect frequencies from spontaneously reported cases of suspected side effects.
A few cases of anaphylaxis have been reported spontaneously with use of Nuvaxovid. Cases of paraesthesia and hypoaesthesia have been reported spontaneously with use of Nuvaxovid (189 paraesthesia and 67 hypoaesthesia cases reported worldwide from more than 1.5 million vaccine doses distributed worldwide by 31 May 2022). Generally, cases reported spontaneously by a patient or healthcare professional concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine.
Safety Update (EMA 17 June 2022): There are currently no safety updates.
Safety Update (EMA 12 May 2022): There are currently no safety updates.
Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
Safety Update (EMA 17 March 2022): No safety updates. Not yet been used in the EU/EEA. [ECDC data from EU Member States as well as countries for the EAA (Norwary, Iceland, Liechtenstein)].
Safety Update (EMA 17 February 2022): No safety updates.
Safety Update (EMA 20 January 2022): No safety updates.
▼Vaxzevria COVID-19 Vaccine (AstraZeneca)
Safety Update (EMA 08 December 2022): Based on continuous safety monitoring and assessments, there are currently no updates to the product information of Vaxzevria. Safety Update (EMA 10 November 2022): There are no safety updates.
Safety Update (EMA 06 October 2022): There are no safety updates.
Safety Update (EMA 14 July 2022, updated 03 August 2022): Tinnitus (persistent ringing in the ears) and paraesthesia (unusual feeling in the skin, such as tingling or a crawling sensation) and hypoaesthesia (decreased feeling or sensitivity, especially in the skin) will be included in the EU product information as a side effect of Vaxzevria. The frequency category will be ‘uncommon’, i.e. occurring in less than 1 in 100 vaccinated persons. Cases of tinnitus and paraesthesia and hypoaesthesia have been reported spontaneously with use of Vaxzevria. Generally, cases reported spontaneously by a patient or healthcare professional concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. In addition, new data on tinnitus paraesthesia and hypoaesthesia was provided from an ongoing clinical trial.
Safety Update (EMA 17 June 2022): There are currently no safety updates.
Safety Update (EMA 12 May 2022): There are currently no safety updates.
Safety Update (EMA 13 April 2022): No updates to the product information currently recommended.
Safety Update (EMA 17 March 2022): The EMA Pharmacovigilance Risk Assessment Committee (PRAC) is aware of results of an epidemiological study based on French national databases and posted on the EPI-PHARE website which suggest a slightly increased risk of myocardial infarction (heart attack) and pulmonary embolism (a blocked blood vessel in the lungs) following vaccination with Vaxzevria. In addition, a slightly increased risk of venous and/or arterial thromboses (blood clots) has been noted in other published studies. PRAC will collect and assess all available data, including data from the marketing authorisation holder, to determine whether the conditions may be caused by Vaxzevria.
Safety Update (EMA 17 February 2022): No safety updates.
Safety Update (EMA 20 January 2022): The product information will be updated to add transverse myelitis (inflammation in the spinal cord) as a side effect. Information on the known side effect of thrombosis with thrombocytopenia syndrome (TTS; blood clots with low blood platelets) will be updated in the product information.
Safety Update (EMA 09 December 2021): No new updates to the product information are currently recommended.
Safety Update (EMA 11 November 2021): Cerebrovascular venous and sinus thrombosis (CVST; blood clots in the brain) without thrombocytopenia (low blood platelet levels) has been observed very rarely following vaccination with Vaxzevria. CVST will be added to the product information as a side effect of Vaxzevria.
Safety Update (EMA 06 October 2021): Immune thrombocytopenia (an autoimmune condition with low blood platelet levels) will be added to the product information as a side effect, together with a warning and advice about thrombocytopenic disorders.
Safety Update (EMA 08 August 2021): The product information will be updated with Guillain-Barré syndrome (GBS) as a side effect of Vaxzevria. Pain in legs and arms or stomach and influenza-like symptoms have also been included in the product information as side effects.
Safety Update (EMA 11 August 2021): No further updates to the product information are currently recommended.
Safety Update (EMA 14 July 2021): Vaccinated persons need to seek immediate medical attention if they develop weakness and paralysis in the extremities, possibly progressing to the chest and face, after vaccination with Vaxzevria, as these could be signs of Guillain-Barré syndrome. The product information will be updated. Vaxzevria is effective in preventing COVID-19.
Safety Update (EMA 18 June 2021): People who have previously had capillary leak syndrome must not receive Vaxzevria. Capillary leak syndrome may also occur as a side effect of Vaxzevria. The product information will be updated. Vaxzevria is effective in preventing COVID-19.
Safety Update (EMA 21 May 2021): Individuals who previously had blood clots with low blood platelets (thrombosis with thrombocytopenia syndrome, TTS) after Vaxzevria must not be given a second dose of Vaxzevria. Individuals with low blood platelets within 3 weeks after vaccination with Vaxzevria should be actively investigated for signs of blood clots; similarly, individuals who present with blood clots within 3 weeks of vaccination should be evaluated for low blood platelets. Patients who have blood clots with low blood platelets after vaccination require specialist medical care. Hypersensitivity reactions presenting as hives or rapid swelling under the skin in areas such as the face, lips, mouth and throat are newly identified side effects of Vaxzevria.
Safety Update (EMA 11 May 2021): Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with Vaxzevria should be actively investigated for signs of thrombosis; similarly, individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia.
Safety Update (EMA 14 April 2021): Very rare, potentially serious, events of unusual blood clots in combination with low blood platelet levels have been confirmed as a new side effect of Vaxzevria.
Safety Update (EMA 29 March 2021): Severe allergic reaction will be included in the product information as a known side effect. A warning on very rare specific blood clot events has been included in the product information, while further investigations into a possible causal relationship with the vaccine are ongoing. Vaccinated persons should seek immediate medical attention if symptoms of blood clotting and/or bleeding occur.
Class information is based on the vaccines currently being used in Ireland. In order to improve traceability of biological medicinals, clearly record the name and the batch number of the administered product.
Contraindications (CI): Hypersensitivity to any member of the class, vaccine component, trace substances after manufacture or following previous admin of a similar vaccine. Use of live viruses with immunosuppression (chemo- or radiotherapy, organ or bone marrow transplantation and/or currently on immunosuppressives including corticosteroids); impaired cell-mediated immunity (HIV infection, Severe Combined Immunodeficiency Syndrome, Di George Syndrome or congenital/hereditary immunodeficiency; severe humoral or cellular, primary or acquired immunodeficiency).
Special Precautions (SP)P: Hypersensitivity and anaphylaxis. Appropriate medical treatment and supervision to be available in case of anaphylactic reaction. Close observation for minimum 15 minutes after vaccination.
Anxiety-related reactions e.g. vasovagal reactions (syncope), hyperventilation or stress-related reactions (dizziness, palpitations, increased heart rate, altered blood pressure, paraesthesia, hypoaesthesia, sweating) may occur in association with the vaccination process itself. Usually temporary and resolve on their own. Advise vaccinees to bring symptoms to attention of vaccination provided to evaluate. Ensure precautions to avoid injury from fainting.
Concurrent illness, postpone (acute severe febrile illness, acute infection); do not delay (minor infection, low-grade fever).
Thrombocytopenia, any coagulation disorder, individuals receiving anticoagulants, weigh risk/benefit of using IM route (bleeding or bruising may occur following IM admin). Vaccines may not protect 100% of recipients; reduced immunogenicity in immuno-compromised (immunosuppressive therapy, genetic causes). Duration of protection is still being determined by ongoing clinical trials.
Driving: Possible side-effects may affect ability. Do not drive if feeling unwell after vaccination.
ATC Code: J07BX03.
Indication(s): Active immunisation to prevent, COVID-19 disease caused by SARS-CoV-2 virus from age 12 years (Comirnaty 30mcg), age 6 years (Spikevax), age 5-11 years (Comirnaty 10mcg); from age 12 years in those who have previously received a primary vaccination course (Comirnaty Original/Omicron BA.1 and BA.4-5).
Dose, Adult: Comirnaty, 30mcg/dose, from age 12 years, 2-dose course (0.3mL each); second dose 3 weeks after first. For injection, the 30mcg/dose concentrate for dispersion (after dilution) and dispersion are considered interchangeable.
Comirnaty Original/Omicron variants (BA.1 or BA.4-5) 15mcg/15mcg/dose, a dose of 0.3mL IM at least 3 months after last prior dose of COVID-19 vaccine.
Spikevax (0.2mg/mL), from age 12 years, 2-dose course (0.5mL each); second dose 28 days after first.
Booster (Comirnaty 30mcg/dose, Spikevax), from age 12 years, may admin a booster at least 3 months after second dose (from age 18 years, Comirnaty 30mcg/dose may be given as booster dose to those who have received a primary course of another mRNA or adenoviral vector vaccine); severely immunocompromised, from age 12 years (Comirnaty 30mcg/dose, Spikevax) or from age 5 years (Comirnaty 10mcg/dose), may admin booster at least 28 days after second dose.
Admin, IM injection, deltoid muscle of upper arm. NOT for IV, SC or intradermal injection.
Dose, Elderly: Age 65 years and older, no dose adjustment.
Dose, Child: Comirnaty (10mcg/dose), age 5-11 years, 2-dose course (0.2mL each); second dose 3 weeks after first.
Spikevax (0.2mg/mL), age 6-11 years, 2-dose course (0.25mL each containing 50mcg i.e. half primary dose for age 12 years and older); second dose 28 days after first.
Booster (third dose), Comirnaty 10mcg/dose, age 5-11 years OR Spikevax, from age 12 years, may admin a booster at least 6 months (Comirnaty) or 3 months (Spikevax) after primary course. Severely immunocompromised, from age 12 years (Comirnaty 30mcg/dose) or age 5-11 years (Comirnaty 10mcg/dose) OR age 6-11 years (Spikevax 0.25mL or 50mcg), may admin booster at least 28 days after second dose.
From age 12 years, Comirnaty (30mcg/dose), Spikevax, see Adult.
Admin, see Adult.
Under 6 years (Spikevax), under 5 years (Comirnaty), safety and efficacy not established.
Interaction(s): Effect of Other Drugs on COVID-19 mRNA Vaccines: No interactions studies performed. High-dose quadrivalent influenza vaccine can be co-admin with Spikevax.
Special Precautions: Individuals vaccinated may not be fully protected until 7 days (Comirnaty) or 14 days (Spikevax) after the second dose. Duration of protection is still being determined by ongoing clinical trials.
Myocarditis, pericarditis risk (very rare); usually within 14 days post-vaccination; more often (after second vaccine, in younger men); risk seems lower in children aged 5-11 years than those aged 12-17 years. Ensure vaccinees understand to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis e.g. (acute and persisting) chest pain, shortness of breath, palpitations (after vaccination). Erythema multiforme (red spots/patches on the skin) and unusual or decreased feeling in the skin.
Anxiety-related reactions, concurrent illness, thrombocytopenia, coagulation disorders, see Class Effects.
Pregnancy, Lactation: Can be used.
Adverse Reaction(s): Summary, most frequent, all brands, injection site pain, fatigue, headache, myalgia, chills, arthralgia; pyrexia, injection site swelling (except Comirnaty BA.1 or BA.4-5). Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
Comirnaty: Safety profile in adolescents aged 5-15 years was similar to age 16 years and older, most frequent, fatigue, headache, myalgia, chills, arthralgia, pyrexia. Age 18 years and older, after booster (third) dose, most frequent, injection site pain, fatigue, headache, myalgia, chills, arthralgia.
Spikevax: Additional, nausea and vomiting, axillary swelling and/or tenderness, fever, injection site redness. Overall, higher incidence of some adverse reactions in younger age groups e.g. axillary swelling or tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea and/or vomiting and fever was higher in ages 18 to under 65 years than in age 65 years and older. Local and systemic reactions were more frequently reported after Dose 2 than after Dose 1.
▼Comirnaty COVID-19 Vaccine, Paediatric (Pfizer)
30mcg/0.3mL per dose, dispersion for injection (concentrate), tozinameran COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Tozinameran [single-stranded mRNA encoding SARS-CoV-2 viral spike (S) protein]. White (off-white) frozen dispersion (conc); must be diluted before use. NOTE: Multidose vial with purple cap.
Excipient(s): Essentially sodium- and potassium-free.
Store: Unopened vial, frozen: 15 months at -90 to -60 deg. When stored at -90 to -60 deg C, can thaw 195-vial packs to 2-8 deg C for 3 hours or individual vials to room temperature (up to 30 deg ) for 30 minutes. Unopened vial, thawed: 1 month at 2-8 deg within 15-month shelf life. Before using: Up to 2 hours up to 30 deg C. Thawed vial, do not refreeze; can handle in room light.
30mcg/0.3mL per dose dispersion for injection, tozinameran COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Tozinameran, as above. White (off-white) frozen dispersion; do not dilute before use. NOTE: Multidose vial with grey cap.
Store: Unopened vial, frozen: 12 months at -90 to -60 deg C. When stored at -90 to -60 deg C, can thaw 10-vial packs 2-8 deg C for 6 hours or individual vials to room temp (up to 30 deg) for 30 minutes. Original pack (light). Unopened vial, thawed: 10 weeks, storage and transport at 2-8 deg C within 12-month shelf-life. Before using: Up to 12 hours between 8-30 deg C. Thawed vial, do not refreeze; can handle in room light.
10mcg/0.2mL dose dispersion for injection (concentrate) paediatric, tozinameran COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Tozinameran, as above. White (off-white) frozen dispersion (conc); must be diluted before use. NOTE: Multidose vial with orange cap.
Store: Unopened vial, frozen: 12 months at -90 to -60 deg C. When stored at -90 to -60 deg C, can thaw 10-vial packs 2-8 deg C for 4 hours or individual vials to room temp (up to 30 deg) for 30 minutes. Original pack (light). Unopened vial, thawed: 10 weeks, store and transport at 2-8 deg C within 12-month shelf-life. Before using: Up to 12 hours between 8-30 deg C. Thawed vial, do not refreeze; can handle in room light.
▼Comirnaty Original/Omicron BA.1 COVID-19 Vaccine (Pfizer)
15mcg/15mcg per dose, dispersion for injection, tozinameran 15mcg, riltozinameran 15mcg per 0.3mL dose COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Single-stranded mRNA encoding SARS-CoV-2 viral spike (S) protein, original (tozinameran) and Omicron BA.1 (riltozinameran). White (off-white) frozen dispersion; do not dilute before use. NOTE: Multidose vial with grey cap.
Store: Unopened vial, frozen: 12 months frozen at -90 to -60 deg C. When stored at -90 to -60 deg, can thaw 10-vial packs to 2-8 deg C for 6 hours or individual vials to room temperature (up to 30 deg C) for 30 minutes. Unopened vial, thawed: 10 weeks storage and transport at 2-8 deg C within 12-month shelf life. Before using: Up to 12 hours between 8-30 deg C. Thawed vial, do not refreeze; can be handled in room light conditions.
▼ Comirnaty Original/Omicron BA.4-5 COVID-19 Vaccine (Pfizer)
15mcg/15mcg per dose, dispersion for injection, tozinameran 15mcg, famtozinameran 15mcg per 0.3mL dose COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Single-stranded mRNA encoding SARS-CoV-2 viral spike (S) protein, original (tozinameran) and Omicron BA.4-5 (famtozinameran). White (off-white) frozen dispersion; do not dilute before use. NOTE: Multidose vial with grey cap. S
Store: Unopened vial, frozen: 12 months frozen at -90 to -60 deg C. When stored at -90 to -60 deg, can thaw 10-vial packs to 2-8 deg C for 6 hours or individual vials to room temperature (up to 30 deg C) for 30 minutes. Unopened vial, thawed: 10 weeks storage and transport at 2-8 deg C within 12-month shelf life. Before using, up to 12 hours between 8-30 deg C. Thawed vial, do not refreeze; can be handled in room light conditions.
▼ Spikevax COVID-19 Vaccine (Moderna)
100mcg per dose, dispersion for injection, elasomeran 100mcg/0.5mL dose COVID-19 mRNA vaccine (embedded in lipid nanoparticles). Single-stranded mRNA (in vitro transcription) encoding SARS-CoV-2 viral spike (S) protein. White (off-white) dispersion. Excipient(s): Essentially sodium-free. Store: Freeze at -50 to -15 deg C. Original pack (light). Can transport as thawed vaccine in liquid state (up to 12 hours at 2-8 degrees C). Do not refreeze.
ATC Code: J07BX03.
Indication(s): Active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus from age 18 years (JCOVDEN, Vaxzevria) OR age 12 years (Nuvaxovid).
Dose, Adult: From age 18 years, JCOVDEN, admin as a single dose (0.5mL). Booster (second dose), of 0.5 mL may be admin IM at least 2 months after the primary vaccination; may admin as a heterologous booster dose completion of primary vaccination with an approved mRNA COVID-19 vaccine (dose interval same as for vaccine used in primary schedule).
From age 18 years, Vaxzevria, admin as a 2-dose course (0.5mL each), between 4 and 12 weeks (28-84 days) apart. Booster (third dose) of 0.5mL may be admin at least 3 months after primary vaccination; may be admin to individuals who completed the primary vaccination course with Vaxzevria or an mRNA COVID-19 vaccine.
From age 12 years, Nuvaxovid, admin as a 2-dose course (0.5mL each), 3 weeks after first dose. From age 18 years, booster (third dose), of 0.5mL may be admin IM at approx. 6 months after the primary vaccination; may admin as a heterologous booster dose completion of primary vaccination with an approved mRNA COVID-19 vaccine or adenoviral vector vaccine (dose interval same as for vaccine used in primary schedule).
Admin, IM injection ONLY, preferably deltoid muscle of upper arm. NOT for IV, SC or intradermal injection.
Dose, Elderly: No dose adjustment.
Dose, Child: Age 18 years and older (JCOVDEN, Vaxzevria) OR 12 years and older (Nuvaxovid), as for Adult. Under 18 years (JCOVDEN, Vaxzevria) OR under 12 years (Nuvaxovid), safety and efficacy not established.
Contraindications: Thrombosis with thrombocytopenia syndrome (TTS) following vaccination; previous episodes of capillary leak syndrome (CLS) (JCOVDEN, Vaxzevria).
Interactions: Effect of Other Drugs on COVID-19 rDNA Vaccines: No interaction studies performed. The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was co-admin with inactivated influenza vaccine (clinical significance unknown).
Special Precautions: Individuals vaccinated may not be fully protected until 14 days after single dose vaccination (JCOVDEN) OR 15 days (Vaxzevria) OR 7 days (Nuvaxovid) after the second dose. Duration of protection is still being determined by ongoing clinical trials.
JCOVDEN, Vaxzevria, thrombosis with thrombocytopenia syndrome (rare), some cases with bleeding, post-vaccination, including severe cases presenting as venous thrombosis at unusual sites e.g. cerebral venous sinus thrombosis, splanchnic vein thrombosis and arterial thrombosis, with thrombocytopenia (some cases fatal). Majority occurred within first 3 weeks post-vaccination, mostly in women (both brands) under age 60 years (JCOVDEN). Thrombosis with thrombocytopenia requires specialised clinical management; consult guidance and/or consult specialists e.g. haematologists, coagulation specialists to diagnose and treat.
JCOVDEN, Vaxzevria, very rarely reported, Guillain-Barré syndrome (GBS) following vaccination. H/care professionals to be alert for GBS signs and symptoms; ensure correct diagnosis (or rule out other causes) and initiate adequate supportive care and treatment. Capillary leak syndrome (CLS) in first days post-vaccination; some cases fatal. CLS characterised by acute episodes of oedema (mainly limbs), hypotension, haemoconcentration, hypoalbuminaemia. Acute CLS episode following vaccination requires prompt recognition, treatment. Intensive supportive therapy usually needed. Do not vaccinate with known CLS history.
Anxiety-related reactions, concurrent illness, thrombocytopenia, coagulation disorders, see Class Effects.
Pregnancy, Lactation: Weigh risk/benefit. Unknown if excreted in human milk.
Adverse Reactions: Summary, most frequent (all brands), injection site pain, headache, fatigue, myalgia, nausea. Reactogenicity was generally milder and reported less frequently in older adults.
Additional adverse reactions, JCOVDEN, pyrexia; most reactions were mild to moderate and of short duration (1-2 days). Nuvaxovid, injection site tenderness, arthralgia, malaise, vomiting; reactions were usually mild to moderate, of duration under 2 days (local events) or 1 day (systemic events). Vaxzevria, pyrexia, injection site tenderness, malaise, chills, arthralgia; most reactions were mild to moderate and usually resolved within a few days; those reported after the second dose were milder and reported less frequently.
▼ JCOVDEN COVID-19 Vaccine (Janssen)
Injection, COVID-19 rDNA 0.5mL (one dose). Recombinant DNA technology. Adenovirus type 26 encoding SARS-CoV-2 Spike (S) glycoprotein (Ad26.COV2-S). Colourless (slightly-yellow) clear (very-opalescent). Excipient(s): Essentially sodium-free; ethanol 2mg/0.5mL. Store, Transport: Freeze (-25 to -15 deg). Can be refrigerated (2-8 deg C) for single period of up to 11 months. Do not re-freeze. Vials in outer carton (light). In-Use (not for storage or transport): Unopened, 9-25 deg C (max. 12 hours).
▼ Nuvaxovid COVID-19 Vaccine (Novavax)
Dispersion for injection, COVID-19 rDNA 0.5mL (one dose). SARS-CoV-2 spike protein adjuvanted with Matrix-M (Fraction A and C of Quillaja saponaria Molina extract). Recombinant DNA technology using aculovirus expression system in insect cell line (Sf9 cells of Spodoptera frugiperda species). Colourless (slightly yellow) clear (mildly opalescent). Excipient(s): Essentially sodium- and potassium-free. Store: Refrigerate (2-8 deg C). Do not freeze. Outer container (light). In-Use (not for storage or transport): Unopened, under 25 deg C (max. 12 hours).
▼ Vaxzevria COVID-19 Vaccine (AstraZeneca)
Injection, COVID-19 vaccine 0.5mL (one dose). Recombinant DNA technology. Chimpanzee Adenovirus encoding SARS-CoV-2 Spike (S) glycoprotein (ChAdOx1-S). Colourless (slightly-brown) clear (slightly-opaque). Excipient(s): Essentially sodium-free; ethanol 2mg/0.5mL. Store: Refrigerate (2-8 deg C). Do not freeze. Vials in outer carton (light).
Page Update: 22 January 2023